Philippines FDA registration IVDR-00815
Elecsys Anti-HBc II
Device information
- Product Name
- Elecsys Anti-HBc II
- Registration Number
- IVDR-00815
Manufacturer details
- Country of Origin
- Germany
Importer & distribution
- Importer/Distributor
- Roche (Philippines) Inc.
Registration dates
- Issuance Date
- July 01, 2025
- Expiry Date
- April 02, 2030
About this record
Access comprehensive regulatory information for Elecsys Anti-HBc II in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number IVDR-00815 and manufactured by Roche Diagnostics GmbH - Sandhofer Strasse 116 68305 Mannheim Germany in Germany. The device was registered on July 01, 2025.
This page provides complete registration details including manufacturer information, importer/distributor details (Roche (Philippines) Inc.), and regulatory compliance data from the official Philippines FDA medical device database. Pure Global AI offers free access to Philippines' complete medical device registry, helping global MedTech companies navigate FDA regulations efficiently.
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